Scoring Systems for Person-Reported Outcome Measurements

• Activity Number: 503
• Type: Topic Contributed
• Date/Time: Wednesday, August 1, 2012 : 10:30 AM to 12:20 PM
• Sponsor: Health Policy Statistics Section
• Author(s): Laura Lee Johnson*+ and Steven D. Edland, Ph.D*+ and M.Colin Ard, Ph.D*+ and Lisa A. Kammerman, Ph.D*+
• Companies: FDA/CDER and National Center for Complementary and Alternative Medicine and University of California at San Diego
• Keywords: patient reported outcomes ; item response theory ; latent models ; Alzheimer's disease

Abstract

Patient, Clinician, and Observer Reported Outcomes all require intensive and structured development. However, for some instruments complicated preliminary work is left behind when scoring systems are devised and implemented. Frequently, responses for distinct items or the number of symptoms are simply added together to compute a total score. Such a practice ignores the potential associations among the individual items and symptoms. Several modern statistical methods employ a variety of techniques to develop scoring systems, including latent variable modeling approaches for rescoring functional outcome measures, will be discussed by the panelists. In recent work a group demonstrated empirically with prior trial data that rescoring can improve the efficiency of clinical trials by at least 15 percent. The panel also will consider the expected report from PCORI (Patient Centered Outcomes Research Institute) on methodological standards for conducting patient-centered outcomes research.